PMA P940035S009
- Device
- NMP22 BLADDERCHEK TEST
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S009
- Product code
- NAH
- Decision date
- 2013-04-02
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- INCREASE THE MANUFACTURING EFFICIENCY OF THE ASSEMBLED CASSETTE BY MODIFYING THE ASSEMBLY METHOD USED IN THE MANUFACTURE OF NMP22 BLADDERCHEK FROM ASSEMBLED AND POUCHED MANUALLY BY HAND BY OPERATORS, TO BE ASSEMBLED BY VALIDATED AUTOMATED EQUIPMENT.
Current openFDA PMA Record#
- Device
- NMP22 BLADDERCHEK TEST
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S009
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2013-04-02
- Decision code
- OK30
- Date received
- 2013-03-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INCREASE THE MANUFACTURING EFFICIENCY OF THE ASSEMBLED CASSETTE BY MODIFYING THE ASSEMBLY METHOD USED IN THE MANUFACTURE OF NMP22 BLADDERCHEK FROM ASSEMBLED AND POUCHED MANUALLY BY HAND BY OPERATORS, TO BE ASSEMBLED BY VALIDATED AUTOMATED EQUIPMENT.